Analytical method for controlled and measured collected internal fluid after surgery

ABSTRACT

A method of analyzing fluid collected from a wound site, the method comprising the steps of: (a) providing a pump unit comprising: one or more pumps, one or more fluid collectors, and one or more drainage structures each in communication with an exit site of the wound site to draw the fluid through the one or more drainage structures into the pump unit and create a negative pressure at the exit site to remove and transport the fluid from the exit site and into the one or more fluid collectors, wherein the pump unit is configured to create a negative pressure, wherein the fluid removal from the exit site is provided at a controlled and measured rate; b) collecting the fluid within the one or more fluid collectors; c) removing the one or more fluid collectors; e) capping the one or more fluid collectors with a cap; and d) analyzing the collected fluid of step “b” once the fluid connectors are removed in step “c”.

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 16/100,188, filed on Aug. 9, 2018, which claimspriority to and is a continuation-in-part of co-pending U.S.Non-Provisional patent application Ser. No. 15/604,254, filed on May 24,2017, which claims benefit of and priority to U.S. ProvisionalApplications Nos. 62/340,853, filed May 24, 2016, now expired, and62/409,400, filed Oct. 18, 2016, expired, and is entitled to priority tothose filing dates. The specifications, drawings, appendices, andcomplete disclosures of U.S. Provisional Applications Nos. 62/340,853and 62/409,400 as well as U.S. Non-Provisional patent application Ser.No. 15/604,254, are incorporated :herein by specific reference for allpurposes.

FIELD OF INVENTION

This invention relates to medical devices, particularly those used todrain serous or serosanguinous fluid from the percutaneous site aftersurgery. Additionally, this disclosure relates to the utilization of adisclosed peristaltic device for uniform and controlled collection ofseroma fluid for analysis thereof.

BACKGROUND OF THE. INVENTION

In order to drain the fluid which naturally builds up after surgeriessuch as mastectomies, abdominoplasties, panniculectomies, hernia repair,and the like, surgeons place drains attached to reservoirs which collectthe bodily fluids for a period of time ranging from several days toseveral months. Once the bulbs are filled, the patient or an aideempties the contents into a measuring cup, measures and reports theamounts of collected fluid to the healthcare provider. The dailycollected amount is the determinant of the clinical decision, i.e., theremoval of the drains. Patients strongly dislike the drains due toquality of life issues, but yet it is their self-reported values thatdetermine the clinical course. This conflict of interest jeopardizes theoptimal care of the patient.

Despite prior attempts to reduce the risk of postoperative seromas dueto large flap forming surgeries, no single technique has been shown toeliminate the risk completely. Current solutions are passive, tend toclog, are ineffective in removing fluid, are much disliked by patientsand healthcare providers, and lack any diagnostic capability.

One of the major issues with post-surgical fluid management is thestorage of the collected fluids. There are large amounts of fluid thatis collected in patients who undergo large void-forming surgeries. Thisresults in large volumes to be collected, measured, and emptied. Thepatients wear graduated bulbs in which fluid is collected and measuredby patients themselves. Multiple issues relate to this: (1) fluid iscollected only after all the air is removed from the abdomen; (2)patients have to pour the fluid in a measuring cup, measure, record,and. report to their healthcare provider, (3) maintenance of sterilityis difficult. In order to effectively remove the fluid in a continuousmanner, air must be removed from the collection reservoir. Otherwise,either the reservoir is filled quickly with air/liquid mixture andemptying must take place to remove fluid often, or the reservoiroverfills leading to high pressure levels and possibly backflow.

Devices which are designed to remove serous or serosanguinous fluid fromthe internal percutaneous space of a patient after surgery arecumbersome for patients to manage and apply severely limited pressure tothe internal space resulting in ineffective drainage and the developmentof blockages in the drainage lines.

Accordingly, there is a need for a device that that addresses theseproblems and issues with a comprehensive approach.

Furthermore, there exists a definite need to improve diagnosticcapabilities as it concerns surgically removed tumors, and the like, asone example of surgical concerns. In essence, even with tumor removal,the chance that cancer cells return and metastatize is significant. Theability to better understand and possibly diagnose such reoccurrencepotential remains a significant question in the medical field. Forinstance, in 2018, more than 1.7 million new cancer cases in the U.S.are projected by the American Cancer Society. For many, curative orpalliative surgery remains the primary treatment with significant riskof recurrence. In pancreatic cancers, 5-year survival rate, aftercurative resection with no residual malignancy and clear margins, is10-30%, attributed mostly to local recurrence. As such, recurrence ormetastasis after curative surgery remains a real concern, which leads todelicate consideration of adjuvant treatment options before or aftersurgery. Local or systemic postoperative adjuvant therapies haveconsiderable long or short-term side effects. Therefore, it is desirableto identify patients that are at high-risk of recurrence foradministration of post-operative therapies based on a variety of factorsincluding disease stage and residual malignancy in the region.Post-operative fluid (seroma) produced in the surgical site has beenconsidered for cytological or biochemical analysis for the detection ofresidual malignancy. However, seroma is produced during the patients'recovery at home and it is not possible or feasible to store, transport,and analyze.

Among the many factors, margin status, an indicator of residualmalignancy, has been shown to correlate with decrease recurrence andre-excision rates. Margin status can be determined post- orintra-operativly. Although intra-operative techniques help in increasingmargins, they are limited to providing information about malignancy onlyat the time of surgery. Margin status can also be detected byhistopathologic analysis of the resected tissue postoperatively butawaiting the results of the analysis may delay adjuvant therapydecisions. Collectively, existing methods inherently lack the capabilityto provide information about dormant malignant cells or cells that maybe in the tissue surrounding the resection and in lymph nodes. As such,there is an increasing interest in the cytological analysis ofpost-operative fluid that is collected by closed suction drains or byfine needle aspirations in the days following a surgery. However, theyremain in academic settings due to limitations of sample collection anddownstream analysis as more and more patients now recover at homefollowing oncologic surgery.

Fluid cytology has a significant role in detecting diseases of the lungand nervous system. Therefore, post-operative fluid (seroma) produced inthe surgical site has been considered another potential specimen forcytological analysis storing information about residual malignancy. In astudy of 142 mastectomy patients, 32 patients had seroma containingmalignant cells postoperative day 6. Since this study in 1986, othershave confirmed the presence of malignant cells in port-operative fluidin pancreatic cancer and breast cancer. The study by Ishikawa et al.showed that patients with benign tumors or non-invasive carcinomas hadno malignant cells in seroma; and, mortality was higher withcontaminated seromas. Most interestingly, by collecting fluid on 3consecutive post-operative days, they showed that for 3 of the 94patients in the study had negative results on first day shifted topositive results on day 2 and 3. This clearly highlights the importanceof daily monitoring after surgeries. In breast surgery, malignant cellswere not found in intraoperative washes, but in fluid collected withclosed suction drains on post-operative day 2 even in those patientswithout axillary metastasis. Greenberg et al detected MUC-1 (atransmembrane protein overexpressed and aberrantly glycosylated inbreast cancer cells) in 25% of the patients in axillary drainagecollected on postoperative day 2. They found a correlation between MUC-1presence and the number of metastatic lymph nodes. These studies providestrong evidence towards the use of post-operative fluid malignancy asmarker of residual disease, which can aid recurrence risk assessment.However, no solutions exist to adequately provide for the repeated,measured, reliable, and convenient collection and analysis of thecollected fluid. This is precisely the benefit of the present invention.

In addition to cytological detection, additional examinations of theseroma fluid was carried out for proteins such as the carcinoembryonicantigen (CAB) and MUC-1 with RT-PCR. In another study, exhaustinganalysis of chemokines, growth factors and cytokines was carried outwith a commercially available array to indicate the differing profilesbetween benign and malignant sites.

Due to technological advances, flow cytometry has become a popular toolin identification of small tumors and circulating rare cells. Modernflow cytometers are able to process fluid samples 1 mL/min rates where10,000 cells/second may be analyzed. In addition, the detectibleparameters have increased to double digits vs 1-2 in the past. As such,the use of flow cytometry to detect rare cells is popular, although withsome limitations. In the case of detection of rare events, it isimperative to reduce processing and maintain the purity of the sample.In addition, it is useful to enhance the signal from the rare cells byfinding labels specific for them. Flow cytometry is a robust,established method requiring minimal sample conditioning prior toanalysis, and is thus a viable candidate technology for scaling of thedevice described herein.

It is clear that there is a strong interest in the analysis of thecontents of the seroma fluid. Cytology is one way this can be achieved,but new advances in flow cytometry and other high throughput methods mayprovide interesting directions in the future. However, the collection ofthe fluid and maintaining its integrity for downstream analysis, whilepatients are mostly recovering at home away from healthcare facility isone problem that needs to he solved. Thus, the primary goal of thisdevice is to enable the downstream analysis of seroma fluid in apatient-friendly manner for home use to unlock the information that iscontained within seroma and to improve post-operative cancer care.

SUMMARY OF INVENTION

In various exemplary embodiments, the present invention comprises asystem and apparatus for the collection of serous or serosanguinousfluid from the percutaneous site after surgery. There are large amountsof fluid that collect in patients who undergo large void-formingsurgeries. This results in large volumes to be collected, measured, andemptied. In order to effectively remove the fluid in a continuousmanner, air must be removed from the collection reservoir. Otherwise,either the reservoir is filled quickly with air/liquid mixture andemptying must take place to remove fluid often, or the reservoiroverfills leading to high pressure levels and possibly backflow.

In several embodiments, the present invention makes use of a poweredsource of negative pressure which helps overcome clogging Observed inprior art devices and one or more reservoirs which allow excess air tobe removed. The invention comprises disposable reservoirs with one-wayvalves that are easy to handle while maintaining sterility and a seal toprevent the loss of vacuum. The present invention further providescontinuous negative pressure suction which assists in providing constantdrainage. Prior art devices do not provide a means of applyingcontinuous negative pressure to the percutaneous wound site.

In addition, the measurements of the output can be performedautomatically, relieving the need for the patient to performmeasurements directly (and thus resolving the potential conflict ofinterest in self-measuring so that the best clinical decisions can bemade). The measurements of output can he relayed to the caregiver,doctor, or the nurse via wired or wireless communications, and enablespatients who do not have companions to manage their drain care. There isa potential diagnostic value in taking various measurements associatedwith the collected fluid. Measurements can include and are not limitedto collected fluid amount, pH, certain known harmful mediators(cytokines, chemokines, reactive oxygen species), protein levels, bloodcontent, etc. For example, amount of fluid collected can be an indicatorof possible seroma development in some hernia surgeries. Additionally,has also been shown to act as an indicator of possible seroma formation.The present invention thus allows for the detection of infectiousmaterials, and any other chemicals or substances which may indicateinfection, or the presence of some medical condition which may naturallyarise in response to the surgical procedure, initial pathology, oradditional complications of either the surgical procedure or the initialpathology) in the fluid collected from percutaneous (internal) wounds.

Additionally, such an invention encompasses, broadly, a method ofanalyzing fluid collected from a surgical wound site, said methodcomprising the steps of:

-   -   a) providing a pump unit including a peristaltic pump, one or        more drainage structures, and one or more fluid collectors,        wherein said pump unit is configured to create a continuous        negative pressure between said peristaltic pump and one or more        drainage structures to draw said fluid through the one or more        drainage structures into the pump unit and create a positive        pressure between the pump unit and one or more fluid collectors        to transport said fluid from the pump unit to the one or more        fluid collectors, wherein said fluid is drained and pumped at a        controlled and measured rate;    -   b) collecting said fluid within said one or more fluid        collectors at a pre-set measured rate to permit ascribing a time        of collection start and finish; and    -   c) analyzing said collected fluid of step “b”. The analytical        methodologies are well known in the medical field, certainly,        and thus such fluid collection and analysis may pertain to any        type of malady or condition that may reflect any type of        surgical and/or bodily fluid collection from a subject patient's        internal organs, glands, and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of the deviceand patient.

FIG. 2 is a perspective view of one embodiment of the deviceincorporated into an abdominal binder.

FIG. 3 is a perspective view of one embodiment of the deviceincorporated into a bra for use after mastectomy.

FIGS. 4A-B are views of exemplary embodiments of drainage structureswhich may be connected to the source of negative pressure.

FIG. 5 is a perspective view of one embodiment of the pump device.

FIG. 6 is a perspective view of one embodiment of the fluid reservoir.

FIG. 7 is a schematic of one embodiment of the device communicationfeatures.

FIG. 8 is a schematic of a different embodiment of the devicecommunication features.

FIG. 9 is a perspective view of one embodiment of a device used tofasten the device to the patient (e.g., abdominal binder, mastectomybra, and the like).

FIG. 10 is a cutaway view of one embodiment of the multiple tubing inputmanifold.

FIG. 11 is a view of one embodiment of a mechanism to prevent excesspressure for building up against the outlet one-way valve.

FIG. 12 is a view of one embodiment of a mechanism to allow thepreservation of the “stripping” or “milking procedure”, and also allowsfor the collection of large materials which may be problematic for thepumps in the device.

FIG. 13 is an exploded view of one embodiment of the device described inthis document.

FIG. 14 is an assembled view of one embodiment of a pump unit inaccordance with an exemplary embodiment of the present invention.

FIG. 15A is a perspective view of the pump housing of FIG. 14 .

FIG. 15B shows front and end views of the pump housing of FIG. 15A.

FIG. 15C shows a bottom view of the pump housing of FIG. 15C.

FIGS. 16-23 show views of an alternative embodiment of a pump unit andreservoir.

FIG. 24 shows a view of inlet ports with mesh.

FIGS. 25A-C show views of inlet ports with a rotary blade.

FIGS. 26A-D show views of a reservoir connection unit with integratedfilters.

FIG. 27 is a schematic of one embodiment of the process of collection,shipment, analysis, and storage of the collected sample described inthis document.

FIG. 28A is a view of one embodiment of the system used to facilitatecollection of the sample, and the means to store the collected sample.

FIG. 28B is a view of one embodiment of the system used to facilitatecollection of the sample and delivery of medically useful material tothe patient, and the means to store the collected sample and medicallyuseful material.

FIG. 29A is a view of several embodiments of the sample-collectionapparatus in the downstream configuration with several embodiments ofmechanisms to store data about the sample on the unit itself.

FIG. 29B is a view of several embodiments of the sample-collectionapparatus in the downstream configuration shown with several embodimentsof mechanisms to remove collected sample from the unit.

FIG. 29C is a view of two embodiments of the sample-collection apparatusin the downstream configuration shown with two embodiments of asample-treatment substance contained in the apparatus.

FIG. 29D is a view of several embodiments of the sample-collectionapparatus in the downstream configuration shown with two embodiments ofa mechanism to remove sample from the apparatus, and one embodiment of amechanism to process the sample without removing sample from theapparatus.

FIG. 29E is a view of one embodiment of the sample-collection apparatusin the downstream configuration shown with one embodiment of a mechanismto remove the sample from the apparatus.

FIG. 30A is a view of two embodiments of the sample-collection apparatusin the upstream configuration shown with two embodiments of a filter tocollect the sample and a mechanism for transporting the sample.

FIG. 30B is a view of two embodiments of the sample-collection apparatusin the upstream configuration shown with two embodiments of sensorsincorporated in the apparatus.

FIG. 31 is a schematic view of one embodiment of a mechanism forautomatically removing, processing, analyzing, or processing andanalyzing sample while in the sample-collection apparatus, and storingsample and sample data from the sample-collection apparatus in alarge-scale operation such as a centralized or decentralized laboratory.

FIG. 32 is a schematic view of one embodiment of a mechanism forautomatically removing, processing, analyzing, or processing andanalyzing sample while in the sample-collection apparatus, and storingsample and sample data from the sample-collection apparatus in asmall-scale operation such as home or hospital setting.

FIG. 33 is a schematic view of one embodiment of the overall process forcollecting and shipping sample from the home to a centralized laboratoryfor sample processing, analyzing, and storing of the sample and sampledata.

FIG. 34 is a schematic view of one embodiment of the overall process forcollecting and shipping sample from the hospital or clinic to acentralized laboratory for sample processing, analyzing, and storing ofthe sample and sample data.

FIG. 35 is a schematic view of one embodiment of the overall process forcollecting and shipping sample from a pharmacy to a centralizedlaboratory for sample processing, analyzing, and storing of the sampleand sample data.

FIG. 36 is a schematic view of one embodiment of the overall process forcollecting and shipping sample from the home to a decentralizedlaboratory for sample processing, analyzing, and storing of the sampleand sample data.

FIG. 37 is a schematic view of one embodiment of the overall process forcollecting and shipping sample from the hospital or clinic to adecentralized laboratory for sample processing, analyzing, and storingof the sample and sample data.

FIG. 38 is a schematic view of one embodiment of the overall process forcollecting and shipping sample from a pharmacy to a decentralizedlaboratory for sample processing, analyzing, and storing of the sampleand sample data.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

In various exemplary embodiments, the present invention comprises asystem and apparatus for the collection of serous or serosanguinousfluid from the percutaneous site after surgery. There are large amountsof fluid that collect in patients who undergo large void-formingsurgeries. This results in large volumes to be collected, measured, andemptied. In order to effectively remove the fluid in a continuousmanner, air must be removed from the collection reservoir. Otherwise,either the reservoir is filled quickly with air/liquid mixture andemptying must take place to remove fluid often, or the reservoiroverfills leading to high pressure levels and possibly backflow.

In several embodiments, the present invention makes use of a poweredsource of negative pressure which helps overcome clogging observed inprior art devices, and one or more reservoirs which allow excess air tobe removed. The invention comprises disposable reservoirs with one-wayvalves that are easy to handle while maintaining sterility and a seal toprevent the loss of vacuum. The present invention further providescontinuous negative pressure suction which assists in providing constantdrainage. Prior art devices do not provide a means of applyingcontinuous negative pressure to the percutaneous wound site.

In addition, the measurements of the output can be performedautomatically, relieving the need for the patient to performmeasurements directly (and thus resolving the potential conflict ofinterest in self-measuring so that the best clinical decisions can bemade). The measurements of output can be relayed to the caregiver,doctor, or the nurse via wired or wireless communications, and enablespatients who do not have companions to manage their drain care. There isa potential diagnostic value in taking various measurements associatedwith the collected fluid. Measurements can include and are not limitedto collected fluid amount, pH, certain known harmful mediators(cytokines, chemokines, reactive oxygen species), protein levels, bloodcontent, etc. For example, amount of fluid collected can be an indicatorof possible seroma development in some hernia surgeries. Additionally,pH has also been shown to act as an indicator of possible seromaformation. The present invention thus allows for the detection ofinfectious materials, and any other chemicals or substances which mayindicate infection, or the presence of some medical condition which maynaturally arise in response to the surgical procedure, initialpathology, or additional complications (of either the surgical procedureor the initial pathology) in the fluid collected from percutaneous(internal) wounds.

FIG. 1 shows an exemplary embodiment of the present system. Drainagestructures 3 begin in the percutaneous space, extend through thepercutaneous tissue at an exit site 2 and terminate in themultiple-drainage-structure manifold 4. A pump 6 creates a negativepressure in the connection 5 between the pump 6 and manifold 4 andimparts a negative pressure to the single or multiple drainagestructures 3. The pump 6, by employing either a peristaltic mechanism,positive displacement, or some other source conveys positive pressure tothe collected fluid after it enters the pump unit, which causes thefluid to be transported to the disposable reservoir 8. A series ofone-way valves which may be placed at either one or all of the followinglocations ensure the prevention of backflow: at the manifold entrance,pump entrance and exit, and reservoir entrance.

The pump 6 is controlled by means of an onboard processor which may takeas inputs from the user the following: on/off; desired pump pressure;and device communication parameters (i.e., mobile device connectivityand the selection of default mobile device). Additionally, the onboardprocessor may take as inputs from the device the following: pumppressure differential (between exit 2 and pump entrance); flow rate atmanifold (for each individual drainage structure or for all drainagestructures combined); motor current draw; device orientation withrespect to force of gravity (from accelerometer); presence of bacterialor pathogenic substances; immune system indicators; battery chargelevel; or any value relevant to the operation of the device.

The device may communicate via Bluetooth or some other communicationprotocol (e.g., BLE, NFC) to a mobile device or to a larger cellularnetwork in order to provide information regarding the performance of thedevice (e.g., battery charge level, need to change reservoir, devicetemperature, current magnitude of negative pressure, presence ofblockage in tubing, or any other relevant information which may be ofbenefit to either the patient, their nurse, their doctor, theircaregivers, their family, or any interested party) and thecharacteristics of the collected fluids. These characteristics mayinclude, but are not limited to, the following: total collected amount(either total or per drainage structure); rate of fluid collection(total or per drainage structure) over one or more time scales (e.g.,hours, days, or weeks); presence of infectious materials; and thepresence of any other chemicals or substances which may indicateinfection or the presence of some medical condition which may naturallyarise in response to the surgical procedure, initial pathology, oradditional complications (of either the surgical procedure or theinitial pathology) in the fluid collected from percutaneous (internal)wounds. This information may be relayed to a mobile computing device,personal computer, or any computer or database system which may beaccessed by the staff of an inpatient or outpatient medical center, thepatient, their nurse, their doctor, their caregivers, their family, orany interested party as allowed by law. This information may be accessedby a purposefully designed mobile application on the mobile computingdevices of the patient, their nurse, their doctor, their caregivers,their family, or any interested party as allowed by law.

FIG. 2 shows a perspective view of a pump 9, manifold 10, and disposablereservoir 11 placed onto an abdominal binder 8. This arrangementcomprises a single unit generally placed at the end of the surgicalprocedure. The device components may connect to the binder by means of aremovable fastening system so that it may be removed from the binder tofacilitate patient comfort. Additionally, the binder may incorporatesome means to secure the drainage structure (drainage tubing) at thesurgical exit site, and along its path to the pump unit. Furthermore thebinder may fasten to itself (forming a continuous loop) by means ofhook-and-loop fabric connection, buckle connector, or button snapconnector(s). The location at which the pump unit attaches to theabdominal binder may incorporate some means of heat mitigation, such as,but not limited to, an open-cell foam pad, or gel-filled plastic pouchtype pad.

In an alternative embodiment, FIG. 3 shows a perspective view of acombined pump, manifold, and disposable reservoir unit 14 placed on abra 13 or mastectomy binder, which is commonly used following amastectomy procedure. This allows a single unit which is generally to beplaced at the end of the surgical procedure. The device 14 may connector be attached to the bra 13 by means of a removable fastener (asdescribed above) so that it may be removed from the binder to facilitatepatient comfort. Additionally, the bra may incorporate some means tosecure the drainage structure (drainage tubing) at the surgical exitsite, and along its path to the pump unit.

FIGS. 4A-B shows views of possible internal drainage structures placedinside of the percutaneous space at the time of surgery. A hollowflexible tube 16, 18 may be perforated, or may incorporate some Crosssection which facilitates the drainage of fluid and prevents tissueingrowth into the tubing. Scaffolding 15, 19 holds the drainagestructure in the conformation which increases surface area. Thescaffolding units may be biodegradable or resorbable, and mayincorporate different geometry, number, or conformation than shown inthe figures. Additionally, these scaffolding units may incorporateantibacterial substances, or any substance which may aid in the tissueapposition of the wound space, healing, infection prevention, blood clotformation, or any other medically useful property. The scaffolding mayadhere to the surface of the drainage tubing or may incorporate suchgeometry as is necessary to allow the scaffolding to completelyencapsulate the drainage tubing at the points of intersection. Thedrainage structure continues 17 through the percutaneous tissue throughthe exit site and terminates at the fluid collection unit or drainagebulb. While the drainage structures shown in FIGS. 4A-B are embodimentsof the unique drainage structure, many other possible configurations arepossible which utilize resorbable or biodegradable scaffolds to form thegeometry of the drainage suture.

FIG. 5 shows a perspective view of one embodiment of the pump mechanism.The top housing (front 28 and rear 23) provides the main structuralsupport for the device and may also provide the contact path necessaryfor the peristaltic action or positive displacement to occur.Furthermore, it may house all necessary electronic components whichinclude, but are not limited to, the microprocessor/microcontroller, thebattery charging components, the user interface components (buttons,switches, displays), the communication components and circuitry, and allnecessary wiring and small components. The peristaltic action isaccomplished by the central rolling mechanism 21 sequentiallycompressing the internal tubing 22 which may consist of silicone rubberor any similar flexible material which may have desirable properties forthis application. The driving force needed to rotate the central rollingmechanism is provided by an electric motor 20 which may be powered byeither a rechargeable or a non-rechargeable battery source. In oneembodiment, the motor is a 6V DC motor with a 90 degree output shaft inorder to reduce the overall device profile. The majority of theelectrical components are contained within the rear device housing 23.This also provides some storage space for batteries.

Sterile, one-way valves 27 prevent backflow of the fluid at both thepump entrance, and also at the pump exit (reservoir entrance). Fluid istransferred from the pump to the reservoir 25 through either directconnection or via additional tubing 24 to allow the reservoir to heplaced at a distance away from the pump. The reservoir may he eithersoft flexible plastic or a hard, rigid container, or a combination ofboth in which a flexible plastic pouch is placed within a rigid outercontainer. As the reservoir 24 is placed downstream from the pump unit,it must provide for the release of excess air which may otherwise becometrapped in the reservoir. Air-permeable, liquid-impermeable membranesmay be incorporated into the reservoir in order to allow this air toescape. Furthermore, the entire reservoir may be comprised of anair-permeable, liquid-impermeable material.

The pump unit may have features which allows it to be easily attached toan abdominal binder, mastectomy binder, or other means of securing thedevice to the patient. Additionally, an insulator (not illustrated) maybe attached to the external surface of the rear device housing 23 toprotect the patient/user from any excess heat generated by the deviceitself during operation. In a further exemplary embodiment, a soundinsulator/reduction component or structure to reduce the sound wavesgenerated by the unit may also be attached to the external surface ofthe rear device housing. The sound insulator/reduction component mayreduce both actual sound volume as well as amplitude thereof, in orderto provide a more comfortable situation for the patient/user.

FIG. 6 shows a cutaway view of an embodiment of the reservoir. Thereservoir is compartmentalized by segmenting structures 34 (in the caseof a rigid reservoir) or by the heat-sealed or pressed structure (in thecase of a flexible pouch-like reservoir). These segmenting structuresprevent the splashing or excessive or irregular movement of fluid 200 inthe reservoir and provide a sequential filling order of the reservoir tolimit the amount of fluid present in the final segment, in whichgas-permeable, liquid-impermeable membranes 32 allow the escape of air.Fluid 200 is transferred from the pump unit into the reservoir through aquick-release connection 28. A one-way valve 29 prevents the backflow offluid when disconnecting the reservoir from the pump unit. A significantdistinction between this reservoir and prior art devices is that thereservoir of the present invention is designed to be disposed of andreplaced by a new, clean reservoir each time the fluid fills areservoir. This significantly improves the patient experience in thatthey no longer must empty the drain reservoir and replace it.

At the end of the reservoir furthest from the intake connection 28 is achamber which may contain some compound 33, such as activated carbon,which both hinders the flow of fluid should it gain entry to thechamber, but also removes any odor from the air which is to be releasedfrom the reservoir. A mesh (foam or otherwise) filter 31 prevents excessfluid from backing up against the first gas-permeable,liquid-impermeable membrane 32. The end segment is constructed in such away as to maximize gas release and minimize the leakage of fluid. In theembodiment shown, three sequential membranes 32 are utilized in order toprevent the escape of fluid from the reservoir.

Additionally, the reservoir may make use of an onboard system(electronic or otherwise) for measuring certain characteristics of thecollected fluid. These characteristics may include, but are not limitedto, the following: total collected amount; rate of fluid collection onthe time scales of hours, days, or weeks; presence of infectiousmaterials; and any other chemicals or substances which may indicateinfection; or the presence of some medical condition which may naturallyarise in response to the surgical procedure, initial pathology, oradditional complications (of either the surgical procedure or theinitial pathology) in the fluid collected from percutaneous (internal)wounds.

For example, in one embodiment the reservoir may make use of afluorescent-based assay for detecting the presence of bacteria, by usinga photosensitive sensor to detect the light emitted by excitation of thefluorescent compound in the presence of bacteria. The reservoir may alsomake use of external graduation markings in combination with atransparent material to allow easy monitoring of fluid collection.Furthermore, in the case of a flexible reservoir design, the reservoirmay comprise an internal pouch and an external rigid structure. As thepouch expands and reaches its maximum till level, it may actuate a limitswitch or proximity switch indicating the reservoir is nearing totalcapacity.

FIG. 7 shows a schematic of one embodiment of a communication channelbetween the pump device 35 and the devices 35, 36 of the staff of aninpatient or outpatient medical center, the patient, their nurse, theirdoctor, their caregivers, their family, or any interested party asallowed by law. This communication is designed to relay informationregarding the function of the device, or the characteristics of thecollected fluid, as described previously. The pump device 35communicates wirelessly with the patient's mobile device 36. tabletcomputer, or personal computer by either device-to-device communicationor by utilizing a local wireless local area network or a cell network.The information received by the patient's device is then relayed in alike fashion (device-to-device, wireless local area network, cellnetwork) to the mobile devices 37, tablet computers, or personalcomputers of the staff of an inpatient or outpatient medical center, thepatient's nurse, their doctor, their caregivers, their family, or anyinterested party as allowed by law. Any of these devices, or the pumpdevice itself, may make treatment recommendations or diagnoses based onthe information gained from the collected fluid.

FIG. 8 shows another embodiment of a communication channel between thepump device 38 and the devices 39, 40, 41, 42 of the staff of aninpatient or outpatient medical center, the patient, their nurse, theirdoctor, their caregivers, their family, or any interested party asallowed by law. This communication is designed to relay informationregarding the function of the device, or the characteristics of thecollected fluid as described previously. The pump device 38 communicateswirelessly with the mobile devices, tablet computers, or personalcomputers of the staff of an inpatient or outpatient medical center, thepatient 39, the patient's nurse, their doctor, their caregivers, theirfamily, or any interested party as allowed by law 40, 41, 42. Any ofthese devices, or the pump device itself may make treatmentrecommendations or diagnoses based on the information gained from thecollected fluid.

FIG. 9 is a perspective view of an exemplary embodiment of an apparatus43 which may function as an abdominal binder, mastectomy bra, or anyother means of attaching the pump device and reservoir to the patient.The apparatus 43 is constructed from fabric or other suitable material,and is backed with a padding or other material 43 a which increases thecomfort to the patient, such as, but not limited to, foam or gelpadding. A series of ports 46 which allow the drainage tubing to passthrough the apparatus are provided at various locations around theapparatus, and may be present in a repeating pattern or spacing. Theapparatus may incorporate a greater or lesser number of these ports thanshown in FIG. 9 .

A tubing channel 44 is provided in the apparatus to allow convenientrouting of the drainage tubing. This channel may secure the tubing bymeans of folding a section hook-and-loop fastener fabric over the tubingalong the length of device or portions thereof. The channel also maycomprise several snap-fit clamps along the length of the apparatus.

A magnified view 48 of the pass-through ports 46 shows in detail theconstruction of the port. The port comprises a foam portion which hasbeen pre-punched or pre-cut 47 in such a way as to allow easy removal ofthe section of foam which has a diameter close to the diameter of thedesired drainage tubing. By incorporating this feature, surgeons maymake use of any diameter drainage tubing, or may utilize severaldifferent sizes of tubing at different locations.

A fastening feature 45 allows the apparatus to be removed easily. Thefeature may function by means of hook-and-loop fabric, button snaps,buckle fasteners, or clasps, The apparatus may also include some featurefor mounting the pump and reservoir, or any other desired peripheraldevices. This feature will match a corresponding feature on the pump andreservoir to allow quick and easy removal, in a manner similar to thatdescribed above, The device also may feature some other means ofsecuring the drainage tubing.

FIG. 10 is a cutaway view of one embodiment of the manifold at the pumpentrance. This manifold allows the connection of one or many drainageinputs. In this embodiment, four input connections are shown; however,the manifold may comprise fewer inputs or greater inputs. Each drainagetubing line 49 is secured to the manifold by a connector 50 (which mayhe a barbed fitting and quick-disconnect combination). This connector 50may allow for the input of many different sizes of drainage tubing viaadaptor fittings or through inherent design. Downstream of the connectoris a one-way valve 51 which prevents backflow of the fluid.

Within the body 54 of the manifold are channels 52 which accept thefluid after the one-way valve 51. These channels 52 direct the fluidinto separate measurement units 53 which collect information about thecharacteristics of the collected fluid. These characteristics mayinclude, but are not limited to, the following: total collected amount;rate of fluid collection on the time scales of hours, days, or weeks;presence of infectious materials; and any other chemicals or substanceswhich may indicate infection, or the presence of some medical conditionwhich may naturally arise in response to the surgical procedure, initialpathology, or additional complications (of either the surgical procedureor the initial pathology) in the fluid collected from percutaneous(internal) wounds. This information may then be relayed to an onboardprocessor 58 for additional processing before being forwarded on to theprocessor in the pump device. A collection unit 55 channels all fluidinto single channel. The manifold may include another one-way valve 56at the exit 57 which may make use of a quick-disconnect connector or maytransfer the fluid directly the pump unit. In this embodiment, themanifold, itself, does not possess any means of moving the collectedfluid but rather relies on the action of the downstream pump device. Themanifold may be separable from the pump device or may be a continuousmolded unit with the body of the pump device.

FIG. 11 shows an overview of a unique mechanism within the peristalticpump device which prevents a high pressure in the system downstream fromthe central rolling unit 63. is useful particularly when the reservoiris removed from its connection to the upstream collected fluid. Aone-way valve or valves may be positioned both before and after thereservoir connection, and the upstream valve likely will have someresidual pressure against it which may cause an amount of fluid to leakwhen the reservoir is disconnected. This mechanism allows the centralrolling unit to automatically reverse, i.e., turn in a directionopposite the direction it must turn to normally pump the fluid. This isachieved via a. spring 65 at the attachment between the motor outputshaft 64 and the body of the central rolling unit 63. When the motor isstopped the spring naturally unwinds or uncoils, causing the centralrolling unit to turn with it some amount. This causes the point at whichthe rollers contact the tubing 66 to shift, causing the fluid to bepushed backwards opposite its normal flow direction. A section ofcompliant tubing 60 allows the influx of excess fluid without causing ahigher than optimal pressure to develop in the tubing. A one-way valve59 prevents the fluid from back flowing through the pump entrance 58.The arrows 58 and 67 show the normal direction of fluid transport. Thedirection of fluid transport caused by this mechanism (when the motor isstopped) is opposite the direction denoted by the arrows. Not shown isthe pump housing, which holds all components and allows the peristalticaction of the pump.

FIG. 12 is an overview of one embodiment of a mechanism to allow thepreservation of a “stripping” or “milking procedure”, and also allow forthe collection of large materials, which can cause problems in thepump(s). The “milking” or “stripping” procedure is currently prescribedas a method to clear blockage in the drainage structure and calls forthe user to apply pressure using their fingers to the tubing above theblockage and, in a peristaltic nature, moving their fingers down thetubing past the blockage, promoting a restored flow. As severalexemplary embodiments of the present utilize a peristaltic; pump, whichoccludes flow if stopped, some mechanism is needed to accommodate the“stripping” or “milking” procedure. This mechanism consists of one ormore one-way valves 68 (generally one per drainage connection)immediately after the connection to the drainage structure, whichprevents backflow of fluid or particles into the tubing Immediatelydownstream of the one-way valve is a chamber (or chambers) 70 to receivefluid and particles, the latter of which may potentially blockdownstream components in the device and inhibit flow. At the exit ofthis chamber is a filter or screen 69, which prevents larger particlesfrom moving further downstream. This entire chamber may be removable, inwhich case seals 74 are incorporated to prevent fluid leakage byoccluding the gap necessary to facilitate removal of the chamber.Downstream of this chamber, the tubing bifurcates with one channelfacilitating fluid transport to the pump(s) 71 and a second “bypass”channel facilitating fluid transport around the pump when the “milking”or “stripping” procedure is performed. A one-way valve 73 is placed inthe second channel to prevent backflow of fluid during normal pumpoperations. The valve remains closed, and the bypass channel thus isshut-off to fluid flow during normal operations. The two tubing channelsconverge to a single channel downstream from the pump and one-way valve,facilitating fluid transport to the remainder of the device 72 or to theoutput reservoir.

FIG. 13 is an exploded view of an exemplary embodiment of an assembleddevice incorporating the elements described above. Fluid inletconnectors 86 (either barbed or otherwise) allow for the connection ofone or multiple drainage structures or tubes (as described above) to thepump unit of the device. in this embodiment, two drainage structures areaccommodated; however, additional structures may be provided for byincluding additional assemblies of the relevant components. For eachfluid inlet, immediately downstream of the connector is a one-way valve,as described above, to prevent the backflow of material into thedrainage structure. Downstream of the one-way valve is a fluid chamber82, which includes a pressure sensor 84 to monitor the pressuredeveloped in the device. Tubing allows fluid from this chamber to flowinto a peristaltic, or positive displacement, pump 83, which appliesnegative pressure on the upstream side of the pump, and positivepressure on the downstream side. This positive pressure downstream ofthe pump causes fluid to be transported through the remainder of thepump housing body and connection elements to a reservoir unit 77.

A set of one-way valves 79, 80 may be incorporated at the connectionbetween the pump housing body and the reservoir to prevent fluid leakageduring change of reservoirs. The reservoirs may he collapsible in naturewhich are much more comfortable to the patient, and may be made in amore economic, and environmentally conscious, way as the collapsiblereservoir will necessitate a smaller volume of plastic to produce. Thereservoir incorporates some means of removably attaching to the pumpbody, which allows the reservoir to be conveniently detached andreplaced by the patient. In this embodiment, a connector 78 is attachedto the reservoir, which mates to a counterpart receptor on the pumphousing body.

As seen in FIG. 13 , the reservoir unit comprises a pair of independentreservoirs as described above. The reservoir thus may contain severalchannels to allow the fluid from multiple drainage structures to beindependently collected. These may be necessary if the healthcareprofessional desires to independently record the collected fluidamounts. Furthermore, the reservoir may be graduated, either by adheringa label or paint to the reservoir, or by embossing the plastic. Thesegraduations allow the fluid collected fluid amount to be easilyassessed.

The reservoir may also contain a substance intended to sterilize thecollected fluid and may also cause the fluid to congeal. This isnecessary for the reservoir to be disposed of as “white bag” waste, orwaste which may be disposed of in landfill without additional treatment.This substance may be contained in a pouch or container within thereservoir or may be freely distributed inside of the reservoir. Thispouch or container may be ruptured by the patient in order to disbursethe contents or may simply dissolve within a convenient period of time.

The reservoir or manifold, or both, may further comprise one or moresensors or measurement devices, internally or externally, or both. Thesesensors provide diagnostic value in taking various measurementsassociated with the collected fluid. Measurements can include and arenot limited to collected fluid amount, pH, certain known harmfulmediators (cytokines, chemokines, reactive oxygen species), proteinlevels, blood content, etc. For example, amount of fluid collected canbe an indicator of possible seroma development in some hernia surgeries.Additionally, pH has also been shown to act as an indicator of possibleseroma formation. The present invention thus allows for the detection ofinfectious materials, and any other chemicals or substances which mayindicate infection, or the presence of some medical condition which maynaturally arise in response to the surgical procedure, initialpathology, or additional complications (of either the surgical procedureor the initial pathology) in the fluid collected from percutaneous(internal) wounds. Sensors may also be located in the pump unit.

Detection of a full reservoir may be accomplished by counting therevolutions of the peristaltic pump, or cycles of the positivedisplacement pump, and then calculating the total displaced fluid. Thisis made possible because the peristaltic, or positive displacement pumpmoves a nearly constant amount of fluid or gas with each revolution ofits motor. The device may be powered by either consumable orrechargeable batteries 85 Which are held in a battery holder.

A circuit control board 81 comprising some or all required electricalcomponents controls the operation of the device. The control board maytake as inputs, and make decisions regarding, the following: user inputsvia interface buttons; battery charge level; need to change reservoir;device temperature; current magnitude of negative pressure; presence ofblockage in tubing; or the characteristics of the collected fluids.These characteristics may include, but are not limited to, thefollowing: total collected amount (either total or per drainagestructure); rate of fluid collection (total or per drainage structure)on the time scales of hours, days, or weeks; presence of infectiousmaterials; and any other chemicals or substances which may indicateinfection, or the presence of some medical condition which may naturallyarise in response to the surgical procedure, initial pathology, oradditional complications (of either the surgical procedure or theinitial pathology) in the fluid collected from percutaneous (internal)wounds.

The user interface may comprise a single push-button 75, which controlsan on/off or pause function, as well as any other functions which aredesirable for the operation of the device. One operation may be theselection of desired level of negative pressure. The interface may alsoconsist of a series of lights or a screen which alerts the user tovarious conditions including, but not limited to, device power state(off/on/paused), selected pressure level, battery charge level, need tochange battery, reservoir till level, need to change reservoir,insufficient vacuum seal at any point in the system, or presence ofinfections materials, and any other chemicals or substances which mayindicate infection, or the presence of some medical condition. Thedevice may apply a negative pressure in the range of 50 mmHg to 700 mmHgbelow ambient pressure either continuously or intermittently or operatesolely in range from 200 mmHg and 700 mmHg below ambient pressure,either continuously or intermittently. The device may create a constantnegative pressure of a desired amount and then allow the motors tomomentarily stop, until a time when the onboard pressure sensors detectthat the applied pressure has fallen below some desired threshold.Alternatively, the pumps may apply pressure based on a time incrementrather than a pressure level.

FIG. 14 shows a perspective view of the assembled pump unit device 87and reservoir 88 as detailed above in the description of FIG. 13 . Inthis embodiment, the pump unit is relatively flat and rectangular, withrounded edges and corners.

FIGS. 15A-C show several views of another exemplary embodiment of theassembled pump unit device. In this embodiment, the edges and cornersmay be more rounded and the entire unit may be curved, as shown. Thefront or top of the device provides a user interface comprising a singlepush-button 90, and lights 96 which indicate the status of the unit(which may include but not be limited to on/off device paused, reservoirfull, or faulty tubing connection). The unit may comprise two (or more,as described above) fluid inlets 91, which provide the connection fortwo drainage structures, and two (or more, to correspond to the fluidinlets) fluid outlets 92, Which allow the fluid to he transported to thecollection reservoir. As seen in FIG. 15C, the housing 93 is curved inorder to conform to the shape of the human abdomen on which the devicewill he worn. The device may curves not only along the horizontal axis(i.e., length-wise), but also along the vertical axis (i.e.,width-wise).

FIGS. 16-23 yet another embodiment of the pump unit 120 and reservoir140 of the present invention, unconnected and connected. FIGS. 20-23show the interior of the pump unit (i.e., with the front half of thepump unit housing removed. In this embodiment, the pump unit 120 iscurved in a similar manner to the pump unit shown in FIGS. 15A-C. A pairof inlet ports/connectors 122 with one-way valves and inlet fluidchambers 134 are located near one end. A push-button interface 124 islocated on the top or front of the pump housing, and a series of lights126 are located on the side near the inlet ports (which is generally thetop side, when the unit is worn). A battery cover 128 allows access tothe batteries 130, which provide power to the circuit control board 132and the pump motors 138. Pumps 136 move fluid to the outletports/connectors 154, which are contained in the reservoir holder 150.Pairs of one-way valves 142 extend from one end of the reservoir unit140 (which contains two independent reservoirs in the embodiment shown)and are inserted into the outlet ports/connectors 154 to attach thereservoir unit to the pump unit. One or more rigid or semi-rigid guides146 may be provided to fit into corresponding slots or holes in thereservoir holder 150. This establishes connection with a sensor orswitch, which enables the control board in the pump unit to determinewhether the reservoir unit is attached, as described below. The guidesalso may help ensure accurate connection and prevent damage to theone-way valves or other connection elements. One or more quick-releasetabs or buttons 152 may be provided to allow the reservoir unit to hedisengaged and easily removed when pressed.

In several embodiments, as seen in FIG. 25 , the fluid inlet ports 310may further comprise a grate or mesh 312, which breaks-up or divides anyparticles or similar larger material in the fluid which may have beencollected during operation. Alternatively, as seen in FIGS. 26A-C, thefluid inlet ports 310 may comprise a rotating blade 320 or rotaryapparatus for the same purpose. The blade 320 may spin within the fixedport by either a powered motor or by the power provided by movement ofthe fluid. In the latter case, the blade has geometry to transform thefluid flow to rotational force, as well as separate geometry to break-upor divide particles or similar larger material as described above.

In yet another exemplary embodiment, filters 340 are provided on areservoir connection unit 330 which is attached to one end of thereservoir unit 140. When the reservoir connection unit is used to attachthe reservoir unit 140 to the pump unit 120, the filter arm 342 withfilters 340 is inserted into a slot in the end of the pump unit, so thefilters 340 are inserted into the fluid flow lines in the body of thepump unit 120. When the reservoir unit is removed (such as by pressingthe quick release latch 348), the reservoir connection unit and filtersare also removed. The reservoir connection unit and filters can bedisposed of with the reservoir. In one embodiment, the filters orreservoir connection unit, or both, may be removable from the reservoirunit, and cleaned for re-use.

In yet another embodiment of the invention, the reservoir unit preventsre-connection to the pump unit after an initial connection to the pumpunit (or other suction apparatus). This prevents re-attachment of apresumably full reservoir unit, and the attempted movement of fluid intoa full fluid collection reservoir.

In a further embodiment of the invention, the pump control unit candetect whether a reservoir unit is connected to the outletports/connections, and prevents normal operation (i.e., the pumping offluid) without a reservoir present to contain the fluid. The detectionmechanism may comprise a mechanical switch or latch, the formation orbreaking of an optical pathway, or similar mechanism appropriate fordetermining or confirming proximity.

The various embodiments of the present invention thus providesubstantial improvements and advantages over the prior art. First, thepresent invention allows multiple drainage tubes to be connected to thesame source of negative pressure. Prior art devices lack thefunctionality to allow the combination of multiple drainage tubes into acommon source of negative pressure, thus requiring patients in surgeriesnecessitating multiple drains to wear multiple instances of thepreviously described device. Second, the present invention also placesthe reservoir after the negative pressure source. Prior art systemsrequire the reservoir to be placed between the tubing leading from theinternal wound site and the source of the negative pressure, whichimpairs functioning of the device. For example, gravity's action on thefluid to provide an air space on which the source of negative pressuremay act prevents prior art devices from functioning optimally while thepatient is in the prone or supine position. Furthermore, the placementof the reservoir in prior art devices increases the working distancebetween the source of negative pressure and the internal wound,necessitating that it acts on a larger volume, reducing the efficiencyof the device, and creating a source of oscillating pressure in the caseof a temporary blockage which is suddenly freed. Third, prior artdevices make use of a perforated internal drain which allows thecollection of fluid. The present system comprises a manifold whichallows the use of the unique internal drain described herein or the useof one or more of the many conventional internal drainage structureswhich the surgeon may prefer. Further, the present inventionincorporates adaptor fittings which allow any size or sizes (in the caseof multiple drain lines) to be utilized.

Additionally, prior art devices prescribe the application of a pressureregime from 125 mmHg to 200 mmHg below atmospheric. At this range, it isunlikely that the device will impart sufficient force on any impedimentto flow which may become lodged in the drainage tubing such as a mass ofclotted blood, fibrous material, or small portion of tissue. The presentinvention may operate at a pressure above 200 mmHg for certain periodsof operation, such as the initial drawing together of the separated(surgically or otherwise) tissue and the clearing of a blockage. Atother times. the present invention may operate at lower pressures inorder to allow a more passive means of suctioning. Further, prior artdevices do not incorporate a disposable reservoir, and do not allowneutralizing any odor from the collected fluid. The present inventioncomprises a fluid reservoir inherently designed to be disposable and isplaced downstream from the source of negative pressure, negating thepreviously described problems with prior art devices.

Prior art devices do not allow for the accurate measurement ofcollection fluid, or derivative measurements. The present inventionallows for the measurement of the amount of collected fluid in eitherthe input manifold or the reservoir, and further calculates thecalculation of the percentage of collected fluid to air which wouldallow for the prediction of poor suturing and possibly surgical siteinfection (SSI). To accomplish this, the present invention carries outthe following steps:

-   -   1. Calculating the amount of total volume (air plus liquid)        collected via counting revolutions of peristaltic rotor.    -   2. Calculating the collected fluid amount by positioning a        series of electrode pairs acting as graduations in the reservoir        or by making use of the fluid measurement units in the manifold.    -   3. Calculating the ratio of total collected volume to total        collected fluid.

As it concerns the analytical (and potentially diagnostic) capabilitiesof the fluid drainage method and processes outlined and describedherein, further considerations are provided within the remaining FIGS.27-38 . FIG. 27 shows an exemplary embodiment of the present system, andoverview of the delivery of the system 402, 403 to the patient 404,normal operation of the system 406,407 in the home or hospitalenvironment 5, and shipping and analysis of the collected bodilymaterial (sample) 408, 409, 410, 411. The sample may be a bodilymaterial belonging to one or more of the following: blood, urine,seroma, serosanginous fluid, wound exudate from an open or closed woundincluding large flap-forming wounds, cells and cellular fragments,cellular debris, cytosol and other cytoplasmic fluid or constituents,proteins and protein-rich fluid, edema, cerebrospinal fluid, synovialfluid, or any other bodily fluid, tissue, or combination of the like.

The sample-collecting apparatus 403 may be connected to a device 402,which enables the sampling of a relevant bodily material and transportof said material to the sample-collecting apparatus. Thesample-collecting apparatus is further described in FIG. 29A-29E. Thedevice may do this by means of physical transfer via biopsy or the like,or through a liquid carrier such as serosangionous fluid. The device maymake use of negative pressure. The device is further described in FIG.28A. 1n this embodiment, the device 402, which facilitates collectionand transfer of the sample to the sample-containing apparatus 403 isplaced onto the patient 404 in the hospital setting 401. The device maybe installed on the patient to be continuously worn or may be removableor transported not attached to the patient. The device may bepre-installed on the patient with one or more sample-containingapparatus 403 or may require attachment at a later time. The device maybe installed on the patient 404 at the time of surgery or at any timeduring the patient's stay in the hospital, at home by a trainedhealth-care provider or lay-person, or in any other appropriate settingincluding an inpatient or outpatient facility during a follow-up visit,a medical supply store, pharmacy, or the like. The device may becontinuously used in the hospital or home setting 405. and may betransported on the patient, or with the patient during all otheractivities outside of the hospital or home setting. The device 406 andsample-containing apparatus 407, may continue to facilitate sampling ofrelevant bodily material over the time the device is used by thepatient. The sample-collecting apparatus 407 may be removed from thedevice 406 and transported by sonic means including courier or othershipping services to a laboratory 408 or other facility for the purposesof analyzing some characteristic of the sample. These characteristicsinclude, but are not limited to those elucidated by fluid cytology, andturbidity, the presence and characteristics of rare cells such ascirculating tumor cells, proteins such as the carcinoembryonic antigen(CAE) and MUC-1, chemokines, growth factors and cytokines, cellulardebris including cytoplasmic fluid, cytosol and proteins, gene profile,pH, cell count, presence of blood, presence of bacteria or otherpathogens or infectious material or evidence of such, cell surfacereceptors or other markers for relevant disease states or conditions.Furthermore, the sample-collecting apparatus 409 may possess featuresthat allow it to pre-process some or all of the desired analysis. Inthis embodiment, the sample, contained in the sample-collectingapparatus is probed by some means for data 410. This data is thenstored, further probed or analyzed alone, or in combination withadditional samples from the same or different patients. The relevantdata or additional results may be transferred to the patient, theircaregiver, health-care provider, or other interested party fordiagnostic, prognostic, or research purposes. Additionally, the sample,itself may be stored, further probed or analyzed alone, or incombination with additional samples from the same or different patients.The sample may be transferred to the patient, caregiver,healthcare-professional, or other interested party for further analysisor storage.

In one embodiment of the device, either the upstream or downstreamsample-collection apparatus, or the device, itself, may contain areservoir of material 423 intended to be delivered to the patient forthe purposes of pain-relief, treatment of disease (including any form ofcancer) or infection, or any other medically-useful purpose. Thismaterial may be delivered at one or more time-points based on severalfactors which are either pre-programmed, determined by the device orsample-collection unit based on patient or sample parameters determinedby onboard analysis, or delivered to the device via some communicationprotocol or feature (e.g. the healthcare provider determines that thedosage of material should be increased, and is able to send instructionsto the device to deliver material accordingly the device may relay thepatient or sample parameters to the healthcare provider for analysis inorder for this determination to be made). The inlet to the device, whichmay include the upstream sample-collection apparatus may possessmultiple cannulae 421, 422 which facilitate motion of fluid both out of,and into the patient. In one embodiment, sample is collected from thepatient, analyzed by the device, and based on that analysis, material asherein described is transferred to the patient via the same or differentcannula.

FIG. 29A-29E show an embodiment of the sample-collection unit orapparatus 424, into which fluid or biological sample is transferredafter a collection process facilitated by a device as described in FIG.28A-28B, or by the sample-collection apparatus itself Furthermore, thesample-collection apparatus may serve as the terminal vessel in whichall further analysis of its contents (i.e. the sample) is carried out,thus ensuring a secure, repeatable, non-contaminated sample during thechain-of-custody from collection to analysis results. Thesample-collection apparatus and its associated packaging may beconstructed to control, either actively or passively, characteristics ofthe sample and any associated packaging which include, but are notlimited to the following: temperature, humidity, UV light transmittanceand absorbance, shock and vibration, fluid ingress or egress, pH, gasingress, egress, ambient concentration or absorbance, or any otherbiologically, clinically, or physically relevant characteristic. In oneembodiment, the sample-collection apparatus is comprised of a flexiblematerial with a specialized connector or inlet 425 which may facilitateeasy installation and removal from the device as described in FIG.28A-28B. The waste collection unit may be divided into one or moreindependent chambers, each of which are individually graduated withvisible markings 426 to allow easy determination of the collected fluid.Furthermore, the sample-collection apparatus may possess some means ofstoring data pertaining to the collected fluid such as an RadioFrequency Identification (RFID) device 427 or barcode or quick response(QR) code 428, 429. The information contained in these devices is notlimited to, but may contain any of the following: date of collection,elapsed time of collection, sample amount, sample chemical or biologicalcharacteristic, sample temperature at any or all times duringcollection, patient or sample identifying information, or shippinginformation.

In one embodiment, the sample-collection unit possesses features tofacilitate removal of the collected sample. The sample-collection unitmay possess perforations 430, 431 at either the top or bottom of theunit, which allow the unit to be easily opened. These perforations maybe created in such a way as to not puncture the entirety of thecollection unit, but rather form weakened points in the material, whichfacilitate origins for tearing or cutting the sample-collection unit.Furthermore, the sample-collection unit may possess a stopcock 432,capped 434 or non-capped. twist-open or squeeze-open outlet to alloweasy removal of stored fluid. Additionally, the sample-collection. unitmay be easily divided into one or more separate collection and analysischambers by means of a perforated seam 433, or other mechanism whichfacilitates separation.

In one embodiment, the sample-collection unit possesses a chemical orbiologically-derived substance intended to preserve, store, or otherwisemodify the sample or sample environment after sample collection. Thissubstance 435 may be placed loosely in the sample-collection unit, ormay be further contained in a pouch, bag, or capsule 436 intended tointroduce the substance to the sample by either degradation, puncturing,bursting, or other method of the pouch, bag, or capsule. The substancemay contain, without any limitation intended, one or more of thefollowing: dilution of alcohol, pH buffer, protease inhibitor,anticoagulant (for blood, protein, or other substance), crosslinker,stain for imaging purposes, cell or DNA fixative, gene, protein,bacteria, or other marker for labeling via immunohistochemistry or othermeans.

In one embodiment, the sample-collection unit may possess a self-sealingsyringe adapter or port 437 at various positions in the unit whichfacilitate easy removal of collected sample by syringe. Furthermore, thesample-collection unit may be constructed in such a way as to create aconical, or otherwise tapered section 440, in order to facilitatecentrifugation of the sample in the sample-collection unit itself, thusavoiding transfer of the sample out of the unit to another vessel (suchas a capped centrifuge tube). The centrifugation of thesample-collection unit may inherently create stratification of thesample constituents 43$, which may be directly removed from the samplecollection unit by syringe adapters or ports or other features whichallows sample collection 439 placed at varying locations on thesample-collection unit. Furthermore, the tapered section may be createdby a separable tube or vessel, which facilitates easy means of transferfrom the sample-collection unit to the vessel; the separable vessel mayallow easier handling and analysis of the sample, while maintaining thesimplicity and security enabled by obviating the need to transfer thesample out of the sample-collection unit.

In a further embodiment of the sample-collection apparatus, the inlet tothe apparatus may possess a feature 441 which allows one-way transfer offluid during collection such as a one-way valve. It may further possessa channel 442 which is appropriately designed to allow the passage of asyringe needle through the inlet and one-way valve to facilitate sampleremoval from the unit. The removal via syringe or similar implement maybe either manually actuated by the patient, a technician or trainedperson, or by automated means.

FIG. 30A-30B shows various embodiments of the sample collection unit inthe upstream configuration, however all of the described features mayalso be implemented in the sample-collection unit in the downstreamconfiguration. In one embodiment, the upstream sample-collection unitpossesses an inlet 443, which may be connected to the patient by somemeans including commonly-used drainage tubing, or wound pad, and anoutlet 446, which may be connected to the device as described in thedetailed description of FIG. 28A-28B one-way valve 444 is placedimmediately after the inlet which is designed to allow the passage ofcollected sample or fluid, but disallow the backflow of material(including air). The sample-collection unit may possess a filter, orseveral filters in either the conical configuration 445, or in anear-perpendicular-to-flow configuration 447, 448, which are selectedbased on filtration size, and are intended to capture various debris inthe sample, for either removal, or collection for further analysis. Theentire sample-collection unit, or one or more filters 449 may beindividually or collectively shipped for further analysis. The filtersor sample collection unit may possess features 450 which allow for thestorage of data which may include but is not limited to date ofcollection, elapsed time of collection, sample amount, sample chemicalor biological characteristic, sample temperature at any or all timesduring collection, patient or sample identifying information, orshipping information. The filters, or collection unit may be shipped ina single or double-bagged container 451, which itself may possessfeatures 452 including barcodes, QR codes, or RFID tags which allow forthe storage of data which may include but is not limited to date ofcollection, elapsed time of collection, sample amount, sample chemicalor biological characteristic, sample temperature at any or all timesduring collection, patient or sample identifying information, orshipping information. The sample-collection unit, filters, or shippingbay may also be capable of communicating with the device (as describedin the detailed description of FIG. 28A-28B), patient, caregiver,healthcare provider, or interested party.

In one embodiment of the sample-collection unit, sensors 53 may be usedto detect parameters including, but not limited to those elucidated byfluid cytology, and turbidity, the presence and characteristics of rarecells such as circulating tumor cells, proteins such as thecarcinoembryonic antigen (CAF) and MUC-1, chemokines, growth factors andcytokines, cellular debris including cytoplasmic fluid, cytosol andproteins, gene profile, pH, cell count, presence of blood, presence ofbacteria or other pathogens or infectious material or evidence of such,cell surface receptors or other markers for relevant disease states orconditions. Furthermore, sensors may be used to determine with thefilter or sample-collection apparatus has reached capacity for thematerial it is intended to collect. The data collected by these sensorsmay be stored in implements in the sample-collection apparatus, filter,or transferred to the device described in the detailed description ofFIG. 28A-28B.

FIG. 31 shows one embodiment of a system for the analysis of thecollected sample. In this embodiment, the sample collection units areconnected to an automated system for the retrieval, processing andanalysis, data storage, and residual sample storage, however one or allof these steps may he partially automated or fully manual. To allow forhigh-throughput of samples, several sample-collection units may becollected to the system concurrently via the same mechanism 454 used toconnect the sample collection units to the device as described in thedetailed description of FIG. 28A-28B. Stationary or automated mechanisms455 may transfer the sample from the collection unit to one or morevessels or machines to be further processed. Prior to the removal ofsample, the automated mechanism may centrifuge one or more of thesamples concurrently or separately using the sample-collection apparatusas the sample-containment vehicle for centrifugation. In the case of anautomated sample removal mechanism, a gantry or robotic shuttlemechanism 456 may facilitate the movement of the sample transfermechanism from one sample-collection unit to another, or fromsample-collection unit to some other vessel or machine to facilitatefurther processing or analysis. A processing or analysis mechanism 458may be used to further process or analyze the sample for characteristicsincluding, but not limited to those elucidated by fluid cytology, andturbidity, the presence and characteristics of rare cells such ascirculating tumor cells, proteins such as the carcinoembryonic antigen(CAE) and MUC-1, chemokines, growth factors and cytokines, cellulardebris including cytoplasmic fluid, cytosol and proteins, gene profile,pH, cell count, presence of blood, presence of bacteria or otherpathogens or infectious material or evidence of such, cell surfacereceptors or other markers for relevant disease states or conditions.Individual fluid paths 457 may be employed to preserve the uniqueness ofthe samples. Sensors or readers 459 installed or incorporated in themechanism may be used to read the RFID, barcode, QR code or otherdata-storage device 460 incorporated in the sample-collection mechanism.These may be one-way or two-way communication protocols. Data read ortransferred may include, but are not limited to date of collection,elapsed time of collection, sample amount, sample chemical or biologicalcharacteristic, sample temperature at any or all times duringcollection, patient or sample identifying information, or shippinginformation. Once all processing is complete, the collected sample, ineither processed or unprocessed form may be stored indefinitely by somemeans 461 for future processing, analysis, or other purposes. All datamay likewise be stored indefinitely by some means 462 for futureprocessing, analysis, or relay of pertinent information to the patient,caregiver, healthcare provider, or interested party. Machine learning,or large data-set processing algorithms may be used in the processing oranalysis of the data.

FIG. 32 shows on embodiment of a dock, or manual, decentralized versionof the machinery described in the detailed description of FIG. 31 . Thisembodiment may be placed in the home, clinic, hospital, pharmacy, orother inherently decentralized location for the processing, analysis,and storage of the sample and associated data, or for relay or immediatedisplay of pertinent information to the patient, caregiver, healthcareprovider, or interested party. The dock 463 may possess a means 464 forconnecting to the sample-collection device using the same methoddescribed in the detailed description of FIG. 31 . Sensors or readers465 installed or incorporated in the mechanism may be used to read theRFID, barcode, QR code or other data-storage device 466 incorporated inthe sample-collection mechanism. These may be one-way or two-waycommunication protocols. Data read or transferred may include, but arenot limited to date of collection, elapsed time of collection, sampleamount, sample chemical or biological characteristic, sample temperatureat any or all times during collection, patient or sample identifyinginformation, or shipping information. The dock may be used to furtherprocess or analyze the sample for characteristics. These characteristicsinclude, but are not limited to those elucidated by fluid cytology, andturbidity, the presence and characteristics of rare cells such ascirculating tumor cells, proteins such as the carcinoembryonic antigen(CAE) and MIC-1, chemokines, growth factors and cytokines, cellulardebris including cytoplasmic fluid, cytosol and proteins, gene profile,pH, cell count, presence of blood, presence of bacteria or otherpathogens or infectious material or evidence of such, cell surfacereceptors or other markers for relevant disease states or conditions.The dock may possess a cartridge or removable set of internal componentsto preserve the uniqueness of different samples from the same ordifferent patients. The dock may possess a screen 467 to display resultsor clinically relevant information about the collected sample, or maytransfer this information to the patient, caregiver, healthcareprofessional, or interested party.

FIG. 33 shows one embodiment of a shipping scheme for the transfer ofthe sample-collection apparatus 468 from the home environment 469 to acentralized processing facility 470. The centralized processing facilitymay contain one or more of the machinery described in FIG. 5 .Alternatively, all processing may be performed manually. Thesample-collection apparatus and its associated packaging may beconstructed to control, either actively or passively, characteristics ofthe sample and any associated packaging which include, but are notlimited to the following: temperature, humidity, UV light transmittanceand absorbance, shock and vibration, fluid ingress or egress, ph, gasingress, egress, ambient concentration or absorbance, or any otherbiologically, clinically, or physically relevant characteristic.

FIG. 34 shows one embodiment of a shipping scheme for the transfer ofthe sample-collection apparatus 471 from the hospital or clinicenvironment 472 to a centralized processing facility 473. Thecentralized processing facility may contain one or more of the machinerydescribed in FIG. 31 . Alternatively, all processing may be performedmanually. The sample-collection apparatus and its associated packagingmay be constructed to control, either actively or passively,characteristics of the sample and any associated packaging whichinclude, but are not limited to the following: temperature, humidity, UVlight transmittance and absorbance, shock and vibration, fluid ingressor egress, pH, gas ingress, egress, ambient concentration or absorbance,or any other biologically, clinically, or physically relevantcharacteristic.

FIG. 35 shows one embodiment of a shipping scheme for the transfer ofthe sample-collection apparatus 474 from the pharmacy environment 475 toa centralized processing facility 476. The centralized processingfacility may contain one or more of the machinery described in FIG. 31 .Alternatively, all processing may be performed manually. In thisembodiment, the patient may bring themselves, or transfer by courier tothe pharmacy, the sample-collection unit to facilitate easy shipping,The sample-collection apparatus and its associated packaging may heconstructed to control, either actively or passively, characteristics ofthe sample and any associated packaging which include, but are notlimited to the following: temperature, humidity, UV light transmittanceand absorbance, shock and vibration, fluid ingress or egress, pH, gasingress, egress, ambient concentration or absorbance, or any otherbiologically, clinically, or physically relevant characteristic.

FIG. 36 shows one embodiment of a shipping scheme for the transfer ofthe sample-collection apparatus 477 from the home environment 478 to adecentralized processing facility 479. The centralized processingfacility may contain one or more of the machinery described in FIG. 5 .Alternatively, all processing may he performed manually. Thesample-collection apparatus and its associated packaging may beconstructed to control, either actively or passively, characteristics ofthe sample and any associated packaging which include, but are notlimited to the following: temperature, humidity, UV light transmittanceand absorbance, shock and vibration, fluid ingress or egress, pH, gasingress, egress, ambient concentration or absorbance, or any otherbiologically, clinically, or physically relevant characteristic.

FIG. 37 shows one embodiment of a shipping scheme for the transfer ofthe sample-collection apparatus 480 from the hospital or clinicenvironment 481 to a decentralized processing facility 482. Thecentralized processing facility may contain one or more of the machinerydescribed in FIG. 31 . Alternatively, all processing may be performedmanually. The sample-collection apparatus and its associated packagingmay be constructed to control, either actively or passively,characteristics of the sample and any associated packaging whichinclude, but are not limited to the following: temperature, humidity, UVlight transmittance and absorbance, shock and vibration, fluid ingressor egress, pH, gas ingress, egress, ambient concentration or absorbance,or any other biologically, clinically, or physically relevantcharacteristic.

FIG. 38 shows one embodiment of a shipping scheme for the transfer ofthe sample-collection apparatus 483 from the pharmacy environment 484 toa decentralized processing facility 485. The centralized processingfacility may contain one or more of the machinery described in FIG. 31 .Alternatively, all processing may be performed manually. In thisembodiment, the patient may bring themselves, or transfer by courier tothe pharmacy, the sample-collection unit to facilitate easy shipping.The sample-collection apparatus and its associated packaging may beconstructed to control, either actively or passively, characteristics ofthe sample and any associated packaging which include, but are notlimited to the following: temperature, humidity, UV light transmittanceand absorbance, shock and vibration, fluid ingress or egress, pH, gasingress, egress, ambient concentration or absorbance, or any otherbiologically, clinically, or physically relevant characteristic.

In order to provide a context for the various computer-implementedaspects of the invention, the following discussion provides a brief,general description of a suitable computing environment in which thevarious aspects of the present invention may be implemented. A computingsystem environment is one example of a suitable computing environmentbut is not intended to suggest any limitation as to the scope of use orfunctionality of the invention. A computing environment may contain anyone or combination of components discussed below, and may containadditional components, or some of the illustrated components may beabsent. Various embodiments of the invention are operational withnumerous general purpose or special purpose computing systems,environments or configurations. Examples of computing systems,environments, or configurations that may be suitable for use withvarious embodiments of the invention include, but are not limited to,personal computers, laptop computers, computer servers, computernotebooks, hand-held devices, microprocessor-based systems,multiprocessor systems, TV set-top boxes and devices, programmableconsumer electronics, cell phones, personal digital assistants (PDAs),tablets, smart phones, touch screen devices, smart TV, internet enabledappliances, internet enabled security systems, internet enabled gamingsystems, internet enabled watches; internet enabled cars (ortransportation), network PCs, minicomputers, mainframe computers,embedded systems, virtual systems, distributed computing environments,streaming environments, volatile environments, and the like.

Embodiments of the invention may be implemented in the form ofcomputer-executable instructions, such as program code or programmodules, being executed by a computer, virtual computer, or computingdevice. Program code or modules may include programs, objects,components, data elements and structures, routines, subroutines,functions and the like. These are used to perform or implementparticular tasks or functions. Embodiments of the invention also may beimplemented in distributed computing envrironments. In suchenvironments, tasks are performed by remote processing devices linkedvia a communications network or other data transmission medium, and dataand program code or modules may be located in both local and remotecomputer storage media including memory storage devices such as, but notlimited to, hard drives, solid state drives (SSD), flash drives, USBdrives, optical drives, and internet-based storage (e.g., “cloud”storage).

In one embodiment, a computer system composes multiple client devices incommunication with one or more server devices through or over a network,although in some cases no server device is used. In various embodiments,the network may comprise the Internet, an intranet, Wide Area Network(WAN), or Local Area Network (LAN). It should be noted that many of themethods of the present invention are operable within a single computingdevice.

A client device may be any type of processor-based platform that isconnected to a network and that interacts with one or more applicationprograms. The client devices each comprise a computer-readable medium inthe form of volatile and/or nonvolatile memory such as read only memory(ROM) and random access memory (RAM) in communication with a processor.The processor executes computer-executable program instructions storedin memory. Examples of such processors include, but are not limited to,microprocessors, ASICs, and the like.

Client devices may further comprise computer-readable media incommunication with the processor, said media storing program code,modules and instructions that, when executed by the processor, cause theprocessor to execute the program and perform the steps described herein.Computer readable media can be any available media that can be accessedby computer or computing device and includes both volatile andnonvolatile media, and removable and non-removable media.Computer-readable media may further comprise computer storage media andcommunication media. Computer storage media comprises media for storageof information, such as computer readable instructions, data, datastructures, or program code or modules. Examples of computer-readablemedia include, but are not limited to, any electronic, optical,magnetic, or other storage or transmission device, a floppy disk, harddisk drive, CD-ROM, DVD, magnetic disk, memory chip, ROM, RAM, EEPROM,flash memory or other memory technology, an ASIC, a configuredprocessor, CDROM, DVD or other optical disk storage, magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devices,or any other medium from which a computer processor can readinstructions or that can store desired information. Communication mediacomprises media that may transmit or carry instructions to a computer,including, but not limited to, a router, private or public network,wired network, direct wired connection, wireless network, other wirelessmedia (such as acoustic, RF, infrared, or the like) or othertransmission device or channel. This may include computer readableinstructions, data structures, program modules or other data in amodulated data signal such as a carrier wave or other transportmechanism. Said transmission may be wired, wireless, or both.Combinations of any of the above should also be included within thescope of computer readable media. The instructions may comprise codefrom any computer-programming language, including, for example, C, C++,C#, Visual Basic, Java, and the like.

Components of a general purpose client or computing device may furtherinclude a system bus that connects various system components, includingthe memory and processor. A system bus may be any of several types ofbus structures, including, but not limited to, a memory bus or memorycontroller, a peripheral bus, and a local bus using any of a variety ofbus architectures. Such architectures include, but are not limited to,Industry Standard Architecture (ISA) bus, Micro Channel Architecture(MCA) bus, Enhanced ISA (EISA) bus, Video Electronics StandardsAssociation (VESA) local bus, and Peripheral Component Interconnect(PCI) bus.

Computing and client devices also may include a basic input/outputsystem (BIOS), which contains the basic routines that help to transferinformation between elements within a computer, such as during start-up.BIOS typically is stored in ROM. In contrast, RAM typically containsdata or program code or modules that are accessible to or presentlybeing operated on by processor, such as, but not limited to, theoperating system, application program, and data.

Client devices also may comprise a variety of other internal or externalcomponents, such as a monitor or display, a keyboard, a mouse, atrackball, a pointing device, touch pad, microphone, joystick, satellitedish, scanner, a disk drive, a CD-ROM or DVD drive, or other input oroutput devices. These and other devices are typically connected to theprocessor through a user input interface coupled to the system bus butmay he connected by other interface and bus structures, such as aparallel port, serial port, game port or a universal serial bus (USB). Amonitor or other type of display device is typically connected to thesystem bus via a video interface. In addition to the monitor, clientdevices may also include other peripheral output devices such asspeakers and printer, which may be connected through an outputperipheral interface.

Client devices may operate on any operating system capable of supportingan application of the type disclosed herein. Client devices also maysupport a browser or browser-enabled application. Examples of clientdevices include, but are not limited to, personal computers, laptopcomputers, personal digital assistants, computer notebooks, hand-helddevices, cellular phones, mobile phones, smart phones, pagers, digitaltablets, Internet appliances, and other processor-based devices. Usersmay communicate with each other, and with other systems, networks, anddevices, over the network through the respective client devices.

Thus, it should be understood that the embodiments and examplesdescribed herein have been chosen and described in order to bestillustrate the principles of the invention and its practicalapplications to thereby enable one of ordinary skill in the art to bestutilize the invention in various embodiments and with variousmodifications as are suited for particular uses contemplated. Eventhough specific embodiments of this invention have been described, theyare not to be taken as exhaustive. There are several variations thatwill be apparent to those skilled in the art.

We claim:
 1. A method of analyzing fluid collected from a wound site, the method comprising the steps of: a) providing a pump unit comprising: one or more pumps, one or more fluid collectors, and one or more drainage structures each in communication with an exit site of the wound site to draw the fluid through the one or more drainage structures into the pump unit and create a negative pressure at the exit site to remove and transport the fluid from the exit site and into the one or more fluid collectors, wherein the pump unit is configured to create a negative pressure, wherein the fluid removal from the exit site is provided at a controlled and measured rate; b) collecting the fluid within the one or more fluid collectors; c) removing the one or more fluid collectors; e) capping the one or more fluid collectors with a cap; and d) analyzing the collected fluid of step “b” once the fluid connectors are removed in step “c”.
 2. The method of claim 1, wherein the one or more fluid collectors include a conical or tapered section that facilitates centrifugation of the sample within the fluid collector.
 3. The method of claim 1, further comprising cutting or tearing the one or more fluid collectors to create an opening by a tear or a cut and removing the fluid through the tear or the cut and placing the fluid into a vessel or a machine.
 4. The method of claim 1, wherein the one or more fluid collectors include a one-way valve that is configured to allow passage of a syringe needle through the one-way valve into the fluid so that a sample of the fluid is taken for further processing.
 5. The method of claim 1, further comprising: removing the cap from the one or more fluid collectors.
 6. The method of claim 1, further comprising: providing a container to receive the one or more fluid collectors so that the one or more fluid collectors are shipped while in the container.
 7. The method of claim 6, wherein the container is a single-bagged container or a double-bagged container.
 8. The method of claim 1, further comprising: sensors located within the one or more fluid collectors, wherein parameters detected by the sensors are configured to detect or indicate infection, proteins, or cell surface receptors.
 9. The method of claim 6, further comprising determining, via the sensors, when the one or more fluid collectors have reached capacity.
 10. The method of claim 1, further comprising measuring an output of the fluid and automatically relaying the output of the fluid measured to a caregiver, a doctor, or a nurse.
 11. The method of claim 6, further comprising: a shipping container and shipping information so that the one or more fluid collectors when placed in the shipping container are shipped to a location on the shipping information.
 12. The method of claim 1, wherein the one or more fluid collectors include membranes that are air-permeable and liquid-impermeable so that air escapes the one or more fluid collectors.
 13. The method of claim 12, further comprising filters that prevent fluid from backing up against the membranes.
 14. The method of claim 1, further comprising: a chemical or substance that indicates: infection, presence of a medical condition that naturally arises in response to a surgical procedure, initial pathology, or additional complications in the fluid collected from the wound site.
 15. A device comprising: a pump unit including one or more pumps configured to move fluid at a pre-set measured rate; one or more fluid collectors connected to receive and collect the fluid from the pump unit, wherein the one or more fluid collectors comprise: one or more sensors located within each of the one or more fluid collectors, and a cap configured to cover each of the one or more collectors; one or more drainage structures connected to the pump unit and extending to a location proximate to a wound site to draw fluid through the one or more drainage structures from the location proximate to the wound site to remove and transport the fluid from the wound site and into the one or more fluid collectors; and wherein the pump unit is configured to create a negative pressure between the one or more pumps and the one or more drainage structures to draw the fluid through the one or more drainage structures and create a positive pressure between the pump unit and one or more fluid collectors to transport the fluid from the wound site into the one or more fluid collectors; and wherein the fluid collected in the one or more fluid collectors is stored in the one or more fluid collectors and capped with the cap so that the fluid in the fluid collectors is shippable to be analyzed at a different location than the sample was collected.
 16. The device of claim 15, further comprising: providing a container to receive the one or more fluid collectors so that the one or more fluid collectors are shipped while in the container .
 17. The device of claim 16, wherein the container is a single-bagged container or a double-bagged container.
 18. The device of claim 15, wherein the one or more sensors located within the one or more fluid collectors are configured detect or indicate infection, proteins, or cell receptors.
 19. The device of claim 16, wherein the one or more fluid collectors include membranes that are air-permeable and liquid-impermeable so that air escapes from the one or more fluid collectors through the one or more fluid collectors.
 20. The device of claim 16, wherein the one or more fluid collectors include a fluorescent-based assay. 